Morton Grove Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities
Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or health risk potential.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL. The recall involves 127,392 bottles packaged in 4 fl oz and 1 pint sizes. The product was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, the product tested out of specification for an unknown degradant/impurity, 4-chlorobenzophenone, and total impurities.
Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 127,392
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot#: a) UU1328
- Exp 10/21
- b) UU1207
- Exp 07/21
- UU1326
- Exp 09/21
- UU1327
- Exp 10/21.
Distribution
Related recalls
Same manufacturer · Morton Grove Pharmaceuticals, Inc.
See all →- ModerateDexamethasone Elixir Recalled for Impurities Above Permissible Levels
FDA (Drugs) · 2022-03-09
- HighPromethazine With Codeine Oral Solution Recall Due to Microbial Contamination
FDA (Drugs) · 2021-09-29
- ModerateValproic Acid Oral Solution recalled for microbial contamination
FDA (Drugs) · 2021-09-29
- ModeratePromethazine Syrup Plain Recall Due to Microbial Contamination
FDA (Drugs) · 2021-09-29
- SevereMorton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
FDA (Drugs) · 2019-10-16
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17